Initially it orders the FDA to compile, with help from the Institute of Medicine, a list of dietary ingredients (read: supplements) that could lead to adverse events or are otherwise deemed risky in some way. But creating lists of “bad” ingredients or “bad” doses based on completely arbitrary or non-existent standards is a slippery slope.

Now Sen. Durbin has proposed an amendment to an appropriations (budget) bill, which is a sneaky way of getting controversial laws passed without too much attention. The amendment would have the Government Accountability Office (GAO) assess the effectiveness and utility of the FDA’s adverse event reporting (AER) system, and report to Congress on what actions FDA is taking to ensure that dietary supplement manufacturers are reporting adverse events; how the AER system “informs the public” of FDA’s efforts to protect consumers; and, most especially, whether FDA has implemented the recommendations GAO made in its 2009 report on dietary supplements.

increased supplement labeling regulations—one of the Durbin bill’s main goals;

a clear delineation to be made between food and supplements—a first step toward treating supplements as drugs—this is also in the Durbin bill, and it’s the particular clause we feared he would slip into the appropriations bill; and

an increase in AER requirements: currently only severe adverse events must be reported, but this would force AERs to be filed even for the most minor events.

The GAO undermined its own recommendation in the report by acknowledging that “FDA officials told us that the current regulatory framework is sufficient to identify and act on safety concerns regarding foods with added dietary ingredients.” This supports ANH-USA’s assertion that the FDA is already well equipped and needs no additional authority to do its job.

Furthermore, the number of supplement AERs is quite low—only 1,080 in 2008. And keep in mind that over half the US population (at least 154 million individuals) take nutritional supplements, according to data from 2007 National Health Interview Survey. The supplement AER figure is even lower when compared to the 526,527 prescription drug AERs in 2008. In other words, for every adverse event from supplements, there are 488 adverse events from prescription drugs!

Remember that it took the deaths of 55,000 Americans before FDA considered pulling Vioxx off the shelves.

The fact that Sen. Durbin has suggested this appropriations amendment indicates that he no longer has high hopes for the Durbin bill. Thanks to all the messages you’ve been sending Congress, he is having a difficult time gaining support for it—he has only been able to find one senator so far who is willing to co-sponsor his bill—and so he’s trying to pressure FDA into implementing the bill’s goals via the regulatory system. We believe it is also an attempt to lay stronger groundwork to push his bill through legislatively, once he gets the ball rolling and FDA starts to treat supplements more like drugs.

We should also note that Sen. Durbin was the architect of the current AER system, but he was unhappy with the political compromise that was struck when the law was passed originally—Sens. Hatch and Harkin agreed to a reporting system so long as it was only for severe events. Now we see Durbin pushing a requirement to have all adverse events be reported, no matter how minor.

What Sen. Durbin clearly wants is for every supplement to be approved by the FDA before it is sold. Everything he does is intended to move things in that direction.

There are fundamental objections to this. First, the FDA is biased in favor of drugs, probably because drugs pay the FDA’s bills. Since the agency sees supplements as competition for drugs, not many will be approved. Second, the agency will demand supplement trials just like drug trials—which is not appropriate for supplements. Supplements are like food: it is the combination and balance of what you take that matters, not just the effect of one pill. Third, the cost of complying with the pre-approval process will make supplements, already beyond many people’s budget, too expensive for all but the rich.

If this powerful senator can’t win using the direct approach, he’ll try an end-run. It may be politics as usual, but when it affects your family’s health, it’s time to fight back. We’ll keep you posted on the maneuvering around appropriations bills.

Click THIS LINK to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter.

We’d also love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by our ANH-USA readers and not Congress.

People have negative reactions to many foods. Does that mean that those foods should not be offered to the public at large, that all foods should be tested and regulated? We know that genetically modified foods harm both nature and the health of individuals, yet they are not regulated. Nothing makes sense anymore!

TO ANH
Thanks for your efforts in stopping this Dietary Supplement Labelling Act.
Could you implement a program that would cause Sen. Dick Durbin to be voted out of office by Illinois supplement users in the next election he runs in? This would also put other members of Congress on notice that they could also be voted out of office, if they support Sen. Durbin’s efforts.
Thanks
Mike Green

Your not being paid enough to kill us or your own family with the drug companies wanting Natural Healing herbs in our vitamins taken out. Do what is right. Look up Alma 46:40 Book of Mormon. Read what the Lord wants us to do. then decide who your going to vote for…

sadly both of my responding congressional representatives, Chuck Schumer and Tim Bishop, seem to be wildly in favor of the Durbin bill and or further supplement regulation. They see nothing wrong with it despite my repeated messages to the contrary. Not surprisingly both are democrats and both voted for Obamacare. K. Gillibrand, my other congressional rep., has not even bothered to respond. That’s typical of her though. I can readily guess where she stands on most issues.

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